(EAGLE Registrations Inc.: Dayton, OH) -- EAGLE Registrations Inc., a third-party certification body that audits businesses to international standards, is now accredited by ANSI-ASQ National Accreditation Board (ANAB) to offer ISO 13485 certification.

“EAGLE is excited to offer accredited ISO 13485 certification to our clients,” says Albert “Skip” Greenaway, president and CEO, EAGLE Registrations. “It provides a solid business foundation, helps meet regulatory and customer requirements and creates competitive business opportunities around the world for medical device manufacturers and suppliers.”

Based on ISO 9001, ISO 13485 is an internationally recognized management system standard for the medical device industry. However, with ISO 13485, the ISO 9001 elements on continuous improvement and customer satisfaction are replaced with maintaining system effectiveness and monitoring customer feedback. The standard also adds risk management criteria and strengthens the requirements for process and software validation.

Businesses interested in learning more about the ISO 13485 standard or certification can contact EAGLE at (800) 795-3641.

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